510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052642Substantially Equivalent

Suturing Washer

First Call, Inc., Derby CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052642 is the FDA 510(k) clearance record for SUTURING WASHER, a class II device, cleared for First Call, Inc. on under FDA product code MAB (Marker, Cardiopulmonary Bypass (Vein Marker)). FDA records list one 510(k) clearance for First Call, Inc. As of , FDA records show no recalls naming K052642.

Clearance record

Decision date
Received
(113 days to decision)
Product code
MAB Marker, Cardiopulmonary Bypass (Vein Marker)
Regulation
21 CFR 870.3450
Device class
Class II
Review panel
Cardiovascular
Applicant
First Call, Inc. P.O. Box 205, Derby CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAB

Trailing 12 months

FDA records hold no clearances under product code MAB in the trailing twelve months.

FDA records show no clearances under product code MAB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MAB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260